IMPACT

Study Name: Improving Metabolic Parameters of Antipsychotic Child Treatment-Multi-site Study - “IMPACT-MS”

IRB #08-1082/GCRC 2717

PI: Linmarie Sikich, MD

Sponsor: National Institute of Mental Health

Contact Person: Lindsey Hazzard

Phone: 1-800-708-0048

E-mail: ASPIRE@unc.edu

Brief Description

This study will examine 3 different approaches (over 24 weeks) to control weight gain and other negative side effects in children and adolescents, ages 8-19, who have been taking an antipsychotic medication and gained a significant amount of weight:

  • continuation of current SGA;
  • Switch to aripiprazole (Abilify) while stopping the current SGA;
  • Add the diabetes drug, metformin + continuation of current SGA.

Subject Payment

Subjects may be paid up to $375 to participate in and complete this study. Study medication (if prescribed) will be provided, outpatient psychiatric care from research staff will be free of charge, and transportation may be provided if needed.

Major inclusion criteria

  • Between the ages of 8 and 19, male or female, any race or ethnicity
  • Diagnosis of Schizophrenia Spectrum Disorder, Bipolar Spectrum Disorder, Depression, Mood Disorder, Autism Spectrum Disorder or are experiencing irritability
  • Currently taking olanzapine, quetiapine, risperidone, ziprasidone, aripiprazole, asenapine, iloperidone, lurasidone, paliperidone, and/or fluoxetine/olanzapine combination and currently stable on current treatment regimen
  • Have gained weight while taking one of these medications

Major exclusion criteria

  • Known hypersensitivity to metformin
  • Current use of a medication known to decrease weight gain – amantidine, histamine (H2) antagonists (cimetidine, ranitidine, nizatidine), topiramate, orlistat, sibutramine, stimulants (dextroamphetamine, methylphenidate) or significantly alter glucose, insulin, or lipid levels (other than currently prescribed psychotropic medications) Exception: orlistat and amantadine are permitted if the individual has taken the drug for at least one year without weight loss.
  • Any current or past diagnosis of an eating disorder
  • Diabetes mellitus or current active thyroid, hepatic, renal, cardiac, gastrointestinal, or adrenal disease
  • Current substance abuse/dependence within past month
  • Pregnancy or breast feeding

Target enrollment

44

Date enrollment closes

TBD

Additional Study-related Resources

IMPACT Study Brochure

National Institute of Mental Health